1. Field of the Invention
The present invention relates to a sealing device for a prefillable container and to an assembly comprising such a sealing device and container in order to obtain a secure prefillable container to be filled with a medicine, for use for example in combination with an infusion pump in treatments where a controlled delivery of a medicine to a patient is needed.
2. Description of Related Art
Infusion pumps devices and systems are well known in the medical art, for use in delivering or dispensing a prescribed medicine such as insulin to a patient. For example, such devices may comprise a compact pump housing adapted to receive a container prefilled with a prescribed medicine for automated administration to a patient through infusion tubing and an associated catheter. The infusion pump is often designed to be extremely compact and may thus be adapted to be carried by the patient, for example, by means of a belt clip. The medicine may then be administered in an automated manner, without significant restriction on the patient's mobility or life-style. In addition, the patient may manage his own treatment by replacing himself an empty container by a new prefilled container in the system he is carrying.
In such a case, it is very important that the prefilled container the patient is provided with be securely sealed until it is needed for use by the patient. In particular, the sealing device of the container may not be removable. Moreover, the sealing device or the sealing step of the container before use must not be at the origin of a contamination of the medicine contained in the container. In addition, the prefilled container must be able to be secured and locked in place in the infusion pump system by the patient in a simple while reliable manner. Indeed, inadvertent displacement of the prefilled container in the infusion pump system, before or during delivery of the medicine, may result in inadequate administration of the prescribed medicine and constitute a danger for the patient. In particular, it would be desirable that the sealing device does not move with respect to the collar of the container, neither axially nor rotationally, during the delivery step of the medicine.
Sealing devices of containers exist which use an aluminum foil which is crimped over the collar of the container. Nevertheless, such sealing devices are not satisfying because the crimping of the aluminum foil over the collar may generate particles capable of contaminating the medicine present in the container.
Moreover, the filling of the empty containers and their sealing usually take place within the premises of the pharmaceutical companies producing the prescribed medicine. These companies must fill in and seal millions of containers and these steps usually take place on assembly lines and are as much as possible completed by automated machines: these steps are therefore reproducible and reliable.
Anyway, the automated sealing of a container filled with a medicine implies that the sealing device may be installed on the collar of a container regardless of the orientation of the sealing device with respect to the collar at the time the sealing step starts, i.e. at the time the sealing device is approached to the collar by a machine.
An aspect of the present invention is to provide a sealing device for a container allowing an optimized sealing step of the container once filled.
An aspect of the invention is a sealing device for a container having a proximal end and a distal end, said distal end being provided with a collar defining an opening aligned on an axis A and provided with an outer flange, said container being provided on its outer wall with at least one outer projection, the sealing device comprising:
a septum sealingly engageable with said opening when said sealing device is mounted on said container,
a cap receiving said septum and capable of receiving at least part of said collar when said sealing device is mounted on said container, said cap comprising retaining means capable of switching from a first position, in which they do not limit the axial movement of said cap with respect to said collar when said sealing device is mounted on said container, to a second position, in which they limit said axial movement under the action of a radial inward force exerted thereon,
a sleeve receiving said cap and movable axially with respect to said cap between a distal position, in which said sleeve does not exert a radial inward force on said retaining means, and a proximal position, in which said sleeve exerts radial inward force on said retaining means,
wherein said sleeve further comprises guiding means capable of cooperating directly or indirectly with said at least one outer projection of said container, so as to limit the rotation of said sleeve with respect to said container when said sleeve is in its proximal position, regardless from the orientation with which the sealing device is mounted on said container.